Edgar Europa
Norridge,IL
Summary
Dynamic Sr. MQA Release Specialist at Fresenius Kabi with a proven track record in quality assurance and safety compliance. Expert in GMP documentation and equipment maintenance, ensuring timely product release. Adept at making critical quality decisions and fostering team collaboration to enhance operational efficiency. Committed to upholding the highest standards in manufacturing processes.
Overview
32
32
years of professional experience
4
4
years of post-secondary education
Work History
Sr. MQA Release Specialist
Fresenius Kabi
Melrose, IL
09.2000 - Current
- Responsible for coordinating and performing the activities of the Manufacturing Quality Assurance (MQA) Disposition department to provide timely audit and release of finished products for commercial distribution.
- Responsible for quality assurance oversight of GMP documentation through the maintenance, control, and audit of manufacturing and testing records to assure compliance with GMP requirements.
- Provides final review and disposition of finished products for commercial batches prior to commercial distribution, and regulatory submission documentation for products in development and product transfers.
- Responsible for making quality decisions and addressing or solving issues based on experience, written procedures, and analytical analysis, supporting batch issuance and batch release processes.
Laboratory Technician
Nycomed Amersham
Rolling Meadows, Illinois
01.1998 - 07.2000
- Conduct laboratory preparation of equipment and materials.
- Operating various functions in manufacturing radioisotope seeds.
- Ensure that all laboratory areas are kept clean and orderly at all times.
- Monitoring safety compliance within the laboratory environment to ensure adherence to regulations.
Packing Machine Operator
American Pharmaceutical Partners
Elk Grove Village, Illinois
03.1994 - 08.1997
- Monitored the production line for equipment malfunctions and safety compliance.
- Conducted routine maintenance on packing machines to minimize downtime.
- Trained new operators on machine operation and safety protocols.
- Coordinated with warehouse staff to manage inventory and packaging supplies.
- Collaborated with team members to improve efficiency and productivity levels.
- Assisted in troubleshooting mechanical issues during production runs.
- Ensured that all safety protocols were followed at all times while operating machinery.
- Adjusted machine settings according to product specifications.
- Provided training on safe operation procedures for new employees.
- Maintained records of production output, downtime, and other related data.
- Coached packers and processing operators by providing courteous support and feedback.
- Collaborated with quality control to ensure product integrity and packaging accuracy.
Education
Bachelor of Arts - Political Science
Saint Louis University
Baguio City, Philippines 06.1986 - 03.1990
Skills
- Quality assurance
- Safety compliance
- Equipment maintenance
- Production monitoring
- SAP
- LIMS
- Trackwise-Deviation/ OOS/ OOT Investigatons
- Documentum
- Batchtrack
Timeline
Sr. MQA Release Specialist
Fresenius Kabi
09.2000 - Current
Laboratory Technician
Nycomed Amersham
01.1998 - 07.2000
Packing Machine Operator
American Pharmaceutical Partners
03.1994 - 08.1997
Bachelor of Arts - Political Science
Saint Louis University
06.1986 - 03.1990
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